Omnicath Implanted Catheter and Depot
FDA 510(k) K911775 · Omnitron Intl., Inc.
510(k) numberK911775
Submission
- Device name
- Omnicath Implanted Catheter and Depot
- Applicant
- Omnitron Intl., Inc.
Houston, TX, US - Received
- April 1, 1991
- Decision date
- May 8, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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More from Isoray Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K901615 | Pulmocath Intrabronchial CatheterJAQ · Traditional | 11/27/1992SE |
| K923130 | IR-192 Implant -- ModificationKXK · Traditional | 09/21/1992SE |
| K920431 | Omnitron Needle Applicators 18 and 21 GaugeJAQ · Traditional | 05/29/1992SE |
| K913908 | Omnitron Gyn Applicator SystemJAQ · Traditional | 03/06/1992SE |
| K915253 | IR-192 Implant, ModificationIWA · Traditional | 02/27/1992SE |
| K881665 | Omnitron Remote Controlled Radionuclide ApplicatorJAQ · Traditional | 08/11/1988SE |
Questions and answers
When was Omnicath Implanted Catheter and Depot cleared by the FDA?
Omnicath Implanted Catheter and Depot (K911775) received a 510(k) decision of Substantially Equivalent on May 8, 1991, 37 days after the submission was received.
What is the product code of K911775?
The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.